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AHCCCS Pharmacy and Therapeutics Committee

August 16, 2016. 5-17-16 Minutes. Review and vote. 2. Reaching across Arizona to provide comprehensive . quality health care for those in need. P&T Meeting Date Changes. 2016 Next Meeting Date: .

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AHCCCS Pharmacy and Therapeutics Committee






Presentation on theme: "AHCCCS Pharmacy and Therapeutics Committee"— Presentation transcript:

Slide1

AHCCCS Pharmacy and Therapeutics Committee

August 16, 2016Slide2

5-17-16 MinutesReview and vote

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quality health care for those in needSlide3

P&T Meeting Date Changes2016 Next Meeting Date:

Wednesday, October 19, 2016

2017

Meeting Dates:

Monday, January 16, 2017

Thursday, April 13, 2017

Tuesday, July 18, 2017

Thursday, October 12, 2017

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P&T Operational PolicyReview and vote

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5

Register to present at least 30 days prior to P&T

Information presented is restricted to randomized double blinded active control studies and published

or

accepted for publication in peer reviewed journal(s)

Limited to 3 minutes per drug per class and 1 representative per drug.

Not accepted:

Online publications

Poster presentations

Placebo-controlled, observational, open-label and non-randomized studies

Anecdotal reports

P&T Operational Policy: Pharma Testimony

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P&T Operational Policy: In-Person Public Comment ProtocolRegister to present at least 14 days prior to

P&T meeting.

First-come, first serve and limited to 15

total in-person public testimonies.

Presenters may not be employed by, speak on behalf of or represent a pharmaceutical manufacturer.

Limited to 3 minutes per

drug.

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Magellan Class Reviews

Classes

Antipsychotics (Atypical, long-acting injectables)

Stimulants and Related Agents

Anticoagulants

Pancreatic Enzymes

New Products (to Magellan PDL classes)

Taltz (Cytokine and CAM Antagonists)

Epclusa (Hepatitis C Agents)

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Antipsychotics

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Antipsychotics

Oral Agents

Abilify (aripiprazole)

Saphris (asenapine)

Rexulti (brexpiprazole)

Vraylar (cariprazine)

Clozaril (cariprazine)

Fazaclo (clozapine)

Versacloz (clozapine)

Seroquel (quetiapine)

Seroquel XR (quetiapine XR)

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Risperdal (risperidone)

Geodon (ziprasidone)

Fanapt (iloperidone)

Latuda (lurasidone)

Zyprexa (olanzapine)

Symbyax (olanzapine/fluoxetine)

Invega (paliperidone ER)

Nuplazid (pimavanserin)Slide10

Antipsychotics

Injectable Agents (Long-Acting)

Abilify Maintena (aripiprazole ER), monthly

Aristada (aripiprazole lauroxil ER), monthly or 6 weeks

Risperdal Consta (risperidone microspheres), 2 weeks

Zyprexa Relprevv (olanzapine), 2-4 weeks

Invega Sustenna (paliperidone palmitate), monthly

Invega Trinza (paliperidone palmitate), 3 months

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Antipsychotics

Class Overview - Product indications include*:

Schizophrenia, Bipolar disorder, major depressive order, schizoaffective disorder, irritability associated with autism, Tourette’s disorder, Parkinson's disease psychosis

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*Not inclusive of all product indications, all products differ in indicationSlide12

Antipsychotics

New Product in Class: Vraylar (cariprazine)

Treatment of schizophrenia and the acute treatment of manic or mixed episodes associated with bipolar I disorder

Black box warning for increased mortality in elderly patients with dementia-related psychosis

Warnings include neuroleptic malignant syndrome, tardive dyskinesia, late-occurring adverse reactions (due to long half-life), metabolic changes, and orthostatic hypotension

Dose should be halved when given concurrently with strong CYP3A4 inhibitors – use with CYP3A4 inducers is not recommended

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Antipsychotics

New Product in Class: Vraylar (cariprazine) continued

Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness are the most common adverse effects

Has not been adequately studied in pregnant women

Given once daily, available in 1.5, 3, 4.5, and 6 mg capsules

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Antipsychotics

New Product in Class: Nuplazid (pimavanserin)

Treatment of hallucinations and delusions associated with Parkinson’s disease psychosis

Black box warning for increased mortality in elderly patients with dementia-related psychosis

Warnings include QT interval prolongation

Dose should be decreased by one half when given concurrently with strong CYP3A4 inhibitors; may need to be increased when given with strong CYP3A4 inducers

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Antipsychotics

New Product in Class: Nuplazid (pimavanserin) continued

Peripheral edema and confused state are the most common adverse effects

There are no data with Nuplazid in pregnant women to inform a drug-associated risk

Given once daily, available in 17 mg tablets

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Antipsychotics

Product/Guideline Updates:

Invega ,Orap and Abilify Discmelt are now available as a generics (September/October 2015)

The American Psychiatric Association practice guidelines on the use of antipsychotics to treat agitation or psychosis in patients with dementia does not provide specific drug recommendations, but mentions risperidone and aripiprazole as effective. Risperidone and olanzapine are addressed as having potential drawbacks in terms of adverse effects. (May 2016)

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Antipsychotics

Product/Guideline Updates:

The FDA reported that DRESS (drug reaction with eosinophilia and systemic symptoms) will be added to olanzapine labeling (all formulations) as a warning. (May 2016)

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Stimulants and Related Agents

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Stimulants and Related Agents

Class Overview:

Immediate Release Products

Amphetamine sulfate (Evekeo)

Dexmethylphenidate IR (Focalin)

Dextroamphetamine IR (Zenzedi)

Dextroamphetamine solution (ProCentra)

Methamphetamine (Desoxyn)Methylphenidate IR (Methylin, Ritalin)

Mixed amphetamine salts IR (Adderall)

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Stimulants and Related Agents

Class Overview: Extended Release Products

Amphetamine ER (Adzenys XR-ODT, Dyanavel XR)

Dexmethylphenidate ER (Focalin XR)

Dextroamphetamine ER (Dexedrine)

Lisdexamfetamine dimesylate (Vyvanse)

Methylphenidate ER OROS (Concerta)

Methylphenidate SR (Metadate ER)

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Stimulants and Related Agents

Class Overview:

Extended Release Products continued

Methylphenidate ER (Metadate CD, Quillichew ER, Quillivant XR, Ritalin LA, Aptensio XR)

Methylphenidate transdermal (Daytrana)

Mixed amphetamine salts ER (Adderall XR)

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Stimulants and Related Agents

Class Overview:

Non stimulants

Atomoxetine (Strattera)

Clonidine ER (Kapvay)

Guanfacine ER (Intuniv)

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Stimulants and Related Agents

Class Overview:

Product Indications

ADHD (attention deficit hyperactivity disorder), narcolepsy

Other: exogenous obesity, binge eating disorder

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Stimulants and Related Agents

New Product in Class: Aptensio XR (methylphenidate)

Treatment ADHD in patients six years and older

Contraindications, warnings, adverse effects, and drug interactions are similar to those for other controlled-release methylphenidate capsules

Given once daily in the morning and comes in 10, 15, 20, 30, 40, 50, and 60 mg extended-release capsules

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Stimulants and Related Agents

New Product in Class: Adzenys XR ODT (amphetamine)

Treatment of ADHD in patients six years and older

Contraindicated with coadministration of MAO inhibitors

Black box warning for high potential for abuse and dependence

Warnings include serious cardiovascular events, serious psychiatric events, long-term growth suppression, increased blood pressure and heart rate, and peripheral vasculopathy

Drug interactions include acidifying agents and alkalinizing agents, which can alter blood levels of amphetamine

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Stimulants and Related Agents

New Product in Class: Adzenys XR ODT (amphetamine)

Loss of appetite, dry mouth, abdominal pain, and insomnia are among reported adverse effects

It is in pregnancy category C

Given once daily in the morning

It is available as a extended-release orally disintegrating tablet in six different strengths (orange flavor)

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Anticoagulants

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Anticoagulants

Class Overview

Injectable Agents

Fragmin (dalteparin)

Lovenox (enoxaparin)

Arixtra (fondaparinux)

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Oral Agents

Eliquis (apixaban)

Pradaxa (dabigatran)

Savaysa (edoxaban)

Xarelto (rivaroxaban)

Coumadin (warfarin)Slide29

Anticoagulants

Class Overview - Product indications include*:

DVT and PE prophylaxis and treatment

Prophylaxis of ischemic complications of unstable angina and non-Q-wave myocardial infarction

Treatment of acute ST-segment elevation myocardial infarction managed medically or with subsequent percutaneous coronary intervention

To reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation

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*Not inclusive of all product indications, all products differ in indicationSlide30

Anticoagulants

Class Overview (Product indications include)*:

Prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement

Reduce the risk of death, recurrent myocardial infarction, and thromboembolic events, such as stroke or systemic embolization after myocardial infarction

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*Not inclusive of all product indications, all products differ in indicationSlide31

Anticoagulants

Product/Guideline Updates:

Praxbind, an intravenous reversal agent for Pradaxa, is now available (October 2015)

Pradaxa is now indicated for prophylaxis of DVT/PE in patients who have undergone hip replacement surgery, along with a new 110 mg strength for dosing convenience (December 2015)

Select portions of the American College of Chest Physicians guidelines were updated in 2016 to include Savaysa as a treatment option along with other oral anticoagulants (DVT/PE treatment) (March 2016)

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Pancreatic Enzymes

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Pancreatic Enzymes

Class Overview: Products

Zenpep

Creon

Viokace

Pancreaze

Pertzye

Ultresa

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Pancreatic Enzymes

Class Overview: Product Indications

Pancreaze, Pertzye, Ultresa, and Zenpep are indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions in both adults and children

Creon is indicated for these conditions, as well as exocrine pancreatic insufficiency due to chronic pancreatitis and pancreatectomy

Other conditions that may result in exocrine pancreatic insufficiency include ductal obstruction from a neoplasm and gastrointestinal bypass surgery

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Pancreatic Enzymes

Class Overview: Product Indications

Viokace is indicated for the treatment of exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatectomy in combination with a proton pump inhibitor in adults only

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New Products (to Magellan PDL classes)

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Taltz (ixekizumab)

Humanized IgG4 monoclonal antibody that inhibits the interleukin-17A (IL-17A) cytokine

Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy

Warnings include serious infections, tuberculosis, and exacerbations of inflammatory bowel diseases

Live vaccines should not be administered with Taltz

Injection site reactions, upper respiratory tract infections, nausea, and tinea infections are the most common adverse effects

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Taltz (ixekizumab)

There are no data in pregnant women to inform a drug-associated risk

Given as two 80 mg subcutaneous injections at weeks 0 followed by one 80 mg injection at weeks 2, 4, 6, 8, 10, and 12, then one 80 mg injection every four weeks

It is available as a 80 mg/mL solution for injection in a prefilled autoinjector or syringe

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Taltz (ixekizumab)

Three multicenter, randomized, double-blind, placebo-controlled trials - total of 3,866 adult patients with plaque psoriasis

Two studies included an active comparator arm in which subjects were also randomized to etanercept 50 mg twice weekly for 12 weeks

Trials evaluated the changes from baseline to Week 12 in 2 co-primary endpoints: 1) PASI 75 and 2)

sPGA

of “0” (clear) or “1” (minimal)

Patients treated with Taltz experienced greater improvement in both primary endpoints than etanercept, as well as statistically significant improvements in itch severity when compared to etanercept at week 12

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Taltz (ixekizumab)

Taltz is the second approved IL-17A inhibitor

Secukinumab (Cosentyx) is approved for plaque psoriasis as well as psoriatic arthritis and ankylosing spondylitis

Taltz joins a list of several other biologics indicated for the treatment of psoriasis

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Epclusa (sofosbuvir/velpatasvir)

Indicated for the treatment of chronic hepatitis C (all genotypes) in adults, with or without cirrhosis

Warnings include bradycardia with amiodarone co-administration

If given with ribavirin, contraindications and warnings for that drug also apply

Drug interactions occur with P-gp inducers and moderate-to-potent CYP inducers; use of Epclusa with these products is not recommended

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Epclusa (sofosbuvir/velpatasvir)

Fatigue and headache are the most common adverse effects

There are no data available in pregnant women to inform a drug-associated risk

Epclusa is given once daily for 12 weeks in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and 12 weeks with ribavirin in patients with decompensated cirrhosis (Child-Pugh B, C)

It is available as sofosbuvir 400 mg and velpatasvir 100 mg combination tablets

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Epclusa (sofosbuvir/velpatasvir)

The efficacy and safety of Epclusa in patients with chronic HCV infection were evaluated in 4 randomized, multicenter, phase 3 trials: the ASTRAL trials

Primary outcome of sustained virologic response at 12 weeks after the end of treatment (SVR12)

Epclusa and resulted in treatment success rates of over 95% in all trials

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AASLD/IDSA Guideline Recommendations*

Genotype 1a and 1b

Zepatier for 12 weeks (compensated cirrhosis)

Harvoni for 12 weeks (compensated cirrhosis)

Harvoni + ribavirin for 12 weeks (decompensated cirrhosis)

Epclusa for 12 weeks (compensated cirrhosis)

Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)

Daklinza + Sovaldi for 12 weeks

Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)

Viekira + ribavirin for 12 weeks

(1a)

Viekira for 12 weeks (compensated cirrhosis)

(1b)

Sovaldi + Olysio for 12 weeks

*Treatment Naïve (not including alternative therapies), July 2016

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AASLD/IDSA Guideline Recommendations*

Genotype 2

Epclusa for 12 weeks (compensated cirrhosis)

Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)

Daklinza + Sovaldi + ribavirin for 12 weeks for decompensated cirrhosis

Genotype 3

Epclusa for 12 weeks (compensated cirrhosis)

Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)

Daklinza + Sovaldi for 12 weeks (for 24 weeks with or without ribavirin for compensated cirrhosis)

Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)

*Treatment Naïve (not including alternative therapies), July 2016

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AASLD/IDSA Guideline Recommendations*

Genotype 4

Zepatier for 12 weeks (compensated cirrhosis)

Harvoni for 12 weeks (compensated cirrhosis)

Harvoni + ribavirin for 12 weeks (decompensated cirrhosis)

Epclusa for 12 weeks (compensated cirrhosis)

Epclusa + ribavirin for 12 weeks (decompensated cirrhosis)

Daklinza + Sovaldi + ribavirin for 12 weeks (decompensated cirrhosis)

Technivie + ribavirin for 12 weeks (compensated cirrhosis)

*Treatment Naïve (not including alternative therapies), July 2016

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AASLD/IDSA Guideline Recommendations*

Genotype 5/6 (with or without cirrhosis)

Harvoni for 12 weeks

Epclusa for 12 weeks

*Treatment Naïve (not including alternative therapies), July 2016

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BH Drug ListSara Salek

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New Drug Reviews Sarah Martinez, PharmD Provider Synergies

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NEW DRUG REVIEWS

Cabometyx

-

Cabozantinib

Descovy

Emtricitabine &Tenofovir

Alafenamide Fumarate

Odefsey

- Emtricitabine, Rilpivirine, & Tenofovir Alafenamide Fumarate

Veltassa

- Patiromer Sorbitex Calcium

Venclexta

-

Venetoclax

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NEW DRUGS REVIEWS continued

The following will not be reviewed:

Cinqair

- Reslizumab

Onzetra Xsail & Zembrance Symtouch (formulations of Sumatriptan)

Sernivo - Betamethasone Dipropionate

Spritam – Levetiracetam

Ultravate Lotion – Halobetasol

Xtampza ER - Oxycodone

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Cabometyx - Cabozantinib S-Malate

Is a Kinase Inhibitor indicated for advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

Dosage – 60mg daily 2 hours prior to or 1 hours after a meal.

No Black Box Warnings

Clinical Trials: Cabometyx was compared to Everolimus in a large muti-center study.

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Cabometyx - Cabozantinib S-Malate

The main outcome measure was progression free survival(PFS).

The PFS for the Cabometyx study arm was approximately twice as long as Everolimus: 7.4 months to 3.8months.

Adverse Reactions occurring in

>

20% of trial participants:

Most are expected with oncology medication, some of the unusual reactions were:

Hair color changes/depigmentation

Oral pain, Dysphonia

Hemorrhoids

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Cabometyx - Cabozantinib S-Malate

Recommendation is to add Cabometyx to the AHCCCS Drug List with prior authorization.

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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)

Indicated for HIV-1 infection in combination with other antiretroviral agents.

Prodrug of Tenofovir Disoproxil Fumarate

Dosage: 1 tablet daily

Black Box Warning:

Lactic Acidosis/Severe Hepatomegaly

HIV-1 and Hepatitis B Coinfection

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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)

Clinical Trials:

Treatment

na

ï

ve

and those on a stable antiretroviral regimen.

FTC

/TAF

w/

Elvitegravir

(EVG)/Cobicistat (COBI)

2 NRTIs + an Integrase Inhibitor + a Booster

92%

Treatment

na

ï

ve

and 96% of replacement regimens had HIV-1 RNA less than 50 copies per ml (48wk)

TAF being promoted as less side effects than Tenofovir Disoproxil.

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Descovy - Emtricitabine (FTC) & Tenofovir Alafenamide (TAF)

Adverse reactions occurring in

>

10% of the trial participants was nausea.

Recommendation is to add Descovy to the AHCCCS Drug List with prior authorization.

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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide

Indicated for HIV

-

1 treatment

infection

in

patients 12 years

of age and older as initial therapy in those with no antiretroviral treatment

history or

to replace a stable antiretroviral regimen in those who are

virologically suppressed

for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual

component.

Dosage: 1 tablet daily

Black Box Warning

Lactic Acidosis/Severe Hepatomegaly

HIV-1 and Hepatitis B

Co-infection

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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide

Clinical Trials

No head to head studies – FDA approval based on bioequivalence studies comparing the pharmacokinetics of Odefsey.

Studies included treatment na

ï

ve and treatment experienced patients

Odefsey contains Tenofovir Alafenamide,

a novel prodrug of tenofovir, which has a short half-live and limited bioavailability in the gastrointestinal

tract.

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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide

The

dose of

Tenofovir Alafenamide (TAF)

is approximately one-tenth of the dose of

Tenofovir Disoproxil Fumarate.

Due to the lower circulating plasma tenofovir levels with TAF,

the drug is being promoted as having lower

off-target side

effects.

Adverse reactions

occurring

in

>

10% of the trial participants were headache, depressive disorders &

insomnia.

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Odefsey – Emtricitabine, Rilpivirine & Tenofovir Alafenamide

Recommendation

is to

add Odefsey to

the AHCCCS Drug List

with prior authorization.

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Veltassa – Patiromer Sorbitex Calcium

Is a non-absorbed potassium binder and indicated to treat hyperkalemia.

Dosage: 1 packet daily

Black Box Warning: Veltassa binds to several oral medications which may affect the effectiveness of the oral agent. Oral medications should be taken 6 hours before or after Veltassa administration.

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Veltassa – Patiromer Sorbitex Calcium

Clinical Trials – Multinational, single-blinded, initial and withdrawal phases.

Results:

Initial phase

:

At the end of week 4, 76%

of patients (N=151)

reached

targeted

serum K+ of 3.8 to <5.1 mmol/L

.

Withdrawal phase:

At

the end of phase

1, participants

were randomly assigned to continue

Veltassa

(n=55) or

switched

to

placebo (N=51)

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Veltassa – Patiromer Sorbitex Calcium

Results continued

Recurrent

hyperkalemia (serum K+ ≥5.1 mmol/L) occurred in 91% of patients in the placebo group versus 43% in the Veltassa group.

Recurrent hyperkalemia (serum K+ ≥5.5 mmol/L) occurred in 60% of patients in the placebo group versus 15% in

the

Veltassa group.

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Veltassa – Patiromer Sorbitex Calcium

Adverse reactions

occurring

in

>

5% of the trial

participants

were hypokalemia, hypomagnesemia, constipation and diarrhea.

Recommendation is to add Veltassa to the AHCCCS Drug List

with prior authorization.

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Venclexta - Venetoclax

Is considered a breakthrough therapy and is indicated

for the treatment of chronic lymphocytic leukemia (CLL) in patients with 17p deletion as detected by an approved test in patients who have received at least

prior

therapy.

This indication is approved under accelerated approval based on the overall response rate. Continued approval for this indication may be contingent upon verification and description of the clinical benefit in a confirmatory trial.

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Venclexta - Venetoclax

Dosage is on

a

titration schedule beginning with 20mg and increasing

until

disease progression of unacceptable toxicity.

Black Box Warnings: None

Clinical Trials: Results of a Phase 2 single arm study with the primary endpoint of Overall Response Rate (OR)

Secondary endpoints of duration of response, progression free survival (PFS) and overall survival (OS) rates.

The estimated PFS and OS at 12 months were 72% and 86% respectively.

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Venclexta - Venetoclax

Adverse reactions occurring in >20% of the trial participants:

Fatigue, hyperkalemia, nausea.

h

yperphosphatemia,

c

onstipation, diarrhea, anemia, neutropenia, thrombocytopenia, and upper respiratory infection.

Recommendation is to add Venclexta to the AHCCCS Drug List with prior authorization.

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